LAWRENCE LIVERMORE NATIONAL LABORATORY
INSTITUTIONAL REVIEW BOARD
IRB Determination of Risk for Investigational Devices (HSR-6) /

LLNL Principal Investigator:

IRB Protocol #:

Device Sponsor:

Sponsor's Risk Assessment: Significant Risk Non-Significant Risk

If this is a Significant Risk Device, please provide the FDA’s IDE number in the space provided below. If this is a Non-Significant Risk device, please provide justification and attach to this form.

IDE Application No.:

Has the device been cleared by the U.S. Food and Drug Administration (FDA) for marketing under the 510(K) process?

Yes No

If so, has the device been changed or modified in any way? (That is, has the design or intended use been changed?)

Yes No N/A

Has the sponsor obtained a new market clearance from the FDA for this change?

Yes No N/A

Did the FDA require the submission of additional clinical data under an IDE for this change?

Yes No N/A

A “Significant Risk Device,” as stated in the regulations [21 CFR 812.3(m)], means an investigational device that:

1)Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;

2)Is purported or represented to be for use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;

3)Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or,

4)Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

A “Non-Significant Risk Device” is one that does not meet any of the criteria above.

______

For IRB Office Use Only

The LLNL IRB has reviewed the device to be used under this protocol and determined the device to be a:

Significant Risk Device / Non-Significant Risk Device

Date of IRB discussion: ______

______

John P. Knezovich, Ph.D.Date

IRB Chairman

Any questions regarding this form should be addressed to the IRB Office. Investigators may call the Office at (925) 422-0260, or e-mail Ann Marie B. Dake, IRB Senior Administrator, at . The Office is located in Building 235, Rom 1021. The mailing address is: Lawrence Livermore National Laboratory, Post Office Box 808, L-350, Livermore, California 94550

Revised: January 2007